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510(k) Data Aggregation
K Number
K133881Device Name
MACY CATHETER
Manufacturer
Date Cleared
2014-01-24
(35 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
HOSPI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
Device Description
The Macy Catheter has been designed for comfort and safety by utilizing a flexible silicone body that enables administration of liquids/medications to the rectum. The device has two lumens, one for administering the liquids/medications and the other for inflation of the retention balloon. The catheter is inserted into the rectum and a small, soft retention balloon is inflated with water via the inflation valve. Liquids/medications are delivered via the medication valve, through the catheter, and into the rectum. The retention balloon can be easily deflated for removal of the catheter. The Macy Catheter remains in the recturn until expelled upon defecation (or removed for defecation if the patient prefers).
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